Contributed By Lopes Muniz Advogados Associados
The manufacturing, distribution, marketing, import and export of medicinal products in Brazil are, mainly, regulated by the National Sanitary Surveillance Agency – ANVISA, the “Regulatory Agency”.
The advertising of pharmaceuticals, as well as of other products that may, as provided for in Article 220 of the Federal Constitution be subject to legal and regulatory restrictions. The limits that the Regulatory Agency should have in the imposition of restrictions on the advertising of non-prescription drugs are the object of heated debate between the regulated sector and the government, including a few judicial discussions.
The main legal instruments that, essentially regulate advertising and promotion of medicinal products in Brazil are the following:
Laws and Decrees
Resolutions and other Ancillary Regulations Issued by ANVISA:
Resolutions of the Federal Council of Medicine – CFM
Self-regulatory codes in Brazil, in general, apply only to members of class associations that have enacted these codes codes. Pharmaceutical Class Associations that have enacted self-regulatory codes to date are:
Brazil also has a National Council of Self-Regulation in Advertising (CONAR) that enacted a Code that regulates public advertising and, in the case of pharmaceutical products, applies exclusively to non-prescription drugs that may be advertised to the public in general. In fact, the CONAR code has a chapter specifically directed to the of advertising of non-prescription medicines. CONAR’s code applies to any advertisement in Brazil, even if the advertiser is not a member.
As a rule, decisions from self-regulatory bodies are not made public but competent authorities and the judiciary may (and do) use decisions issued by self-regulatory bodies as basis for their decisions if these decisions are brought to their attention.
ANVISA defines the advertising/publicity of pharmaceutical products in Resolution RDC 096/2008, as: “the array of information and persuasion techniques and activities with the objective of publicising knowledge, making a product or trademark more widely known or object of prestige, aiming to influence the public by means of actions intended to promote and/or induce the prescription, dispensing, purchasing and use of a medicinal product”.
Initially, it is important to keep in mind that advertising of prescription drugs to the lay public is prohibited in Brazil. That said, as a rule, information will usually be seen as “advertising” if it includes products’ trade marks and standard promotional messages.
The category of “information” would include disease awareness campaigns, including leaflets and other information directed to patients and/or to the general public, which are widely used in Brazil. This includes health related campaigns made by private industries and do not qualify as advertising.
In fact, Brazilian health authorities implement several campaigns each year especially related to vaccines, AIDS prevention, hepatitis, flu and tropical diseases. In disease awareness campaigns, it is prohibited to mention any specific trade mark or name of medicinal product. The campaigns must simply provide an incentive for the population to consult with healthcare professionals for diagnosis or to go to doctors or health clinics (private or public) for vaccination.
Press release are allowed in Brazil and widely used. Although there is no specific legislation regulating to this issue, in some cases health authorities have argued that some releases (or articles published in lay media) were, in fact, disguised “advertising”. Because of that, in preparing press releases the use of trade marks or trade names should be avoided in favour of using the name of the active ingredient.
Comparative advertising is allowed and RDC 096/2008 sets forth the rules to guide authorised comparisons.
Price comparison are only allowed between medicines considered as interchangeable under applicable law and regulations. As a rule, interchangeable medicines would be “Reference Products” X “Generics”. In the case of Brazil, although “Similar Products” (generics bearing trade marks) must demonstrate bioequivalence to the Reference Product comparative advertising is still the object of some discussion.
Comparative advertising, in general, must also abide by several different pieces of legislation and regulations, including:
Self-regulation and Code of Conduct
CONAR’s National Code of Self-Regulation in Advertising states that all comparative advertising must be done over objective aspects of the products and that the advertiser must be able to prove the compared aspects. Also, it is forbidden to depreciate the compared brand or to create confusion between the products.
The INTERFARMA Code of Conduct, for instance, prohibits comparative advertising with the use of third-party brands without their prior consent. However, it does allow comparisons between active ingredients even if indirect identification of brands could be possible. Any decision to engage in comparative advertising must be carefully evaluated
The provision of information about unauthorised medicines and/or unauthorised indications (off-label), as a rule, are not allowed in Brazil. Some information may be provided in medical events or through press releases but, as mentioned, the use of trade marks should be avoided.
Information on unauthorised medicinal products and/or off-label information can only be published as scientific information. Because of this, if the product already has a trade mark its use should be avoided. The INTERFARMA Code of Conduct sets forth that information on unregistered products or on off-label indications may only be used in the context of medical and scientific information at congresses, symposiums or other scientific events.
If any company does disclose information on unauthorised medicines, the audience must be duly and previously informed that the product is not yet available in the market or that the use object of the information has not been approved by the regulatory authorities.
Although Brazilian pharmaceutical legislation and ancillary regulations strictly prohibit the advertising of medicinal products that are not registered by the Regulatory Agency (ANVISA), not yet authorised products may be discussed at scientific events (congresses, symposia, etc), whether the event is sponsored soley by the company responsible for the product or not. These discussions must be restricted to technical information like important findings in ongoing clinical studies, for example, and should not use product trademarks to avoid being perceived as an inducement to prescribe.
It should be noted that the legislation does not mandate a previous request from the healthcare professional. However, the INTERFARMA Code of Conduct states that this type of information, in principle, can only be sent if requested by the professional.
The same rules apply to off-label information. In this case, too, it is advisable not to use the trade mark of the product, but instead just the name of the active ingredient.
See 3.3 Provision of Information to Healthcare Institutions.
There is no specific regulation on the publication of availability of compassionate programmes.
It is important to sat that while the production, distribution and of medicinal products that are not yet registered by ANVISA are prohibited, it is possible for an individual to import non-registered products for their own use, independent from previous authorisation. For this it is only necessary to provide the importer with a specific prescription from a medical doctor duly registered to practise medicine in Brazil.
Importation for groups of patients can only be made through “compassionate use” or “expanded access” programs that depend on ANVISA’s previous authorisation, but, as a rule, no public information is released. These types of programmes are mainly used in relation to patients who have participated in Clinical Studies for access to the study drugs after the end of the study while the product is undergoing the registration procedure.
Only over-the-counter (OTC) pharmaceuticals can be advertised to the general public in Brazil. Prescription-only products can only be advertised to prescribing professionals. While no restriction apply for OTC medicines, advertising guidelines must be followed.
Advertisement of medicinal products to the public in Brazil must always include the following generic warnings:
The above-mentioned warnings must be included, unless an additional warning related to a specific active ingredient is required by health authorities in relation to any product.
Restrictions on Advertising Non-prescription Medicinal Products
The following restrictions also apply to the advertising of non-prescription medicinal products:
Advertising to Professionals
Even considering that advertising can only be made to prescribing professionals, the advertising of any medicinal product, cannot:
There is very little legislation and/or ancillary regulations on the subject so, as a rule this is allowed. The INTERFARMA Code of Conduct, different from the legislation, does expressly address the issue. The Code, for instance, expressly prohibits the industry from interfering with the administration of the organisation or participating in it. The Code also prohibits an industry from being the sole contributor to any organisation.
Because of the high level of judicialisation of health treatment in Brazil, health authorities have been maintaining a very close look on the relationship between the industry and patient associations.
Authorities believe, and in some cases found it to be true, that some donations made to patient support groups where being used to pay for legal fees and expenses necessary for patients to sue the government in order to receive treatment (medicines or medical treatment) not yet available in the public system or not yet registered in Brazil. Note that under the interpretation of the Constitution by the Courts, the government is obliged to provide medicines, for free, for those that cannot pay for them.
Most police investigation made over the past decade ended without finding hard evidence on the alleged financing of patient associations for the purpose of subsidising the judicialisation but there a few cases that are still ongoing. Most of these cases refer to “high cost” and “high complexity” medicines.
The judicialisation of health is a big issue in Brazil.
This is regulated under RDC 096/2008. The required information in advertising to healthcare professionals are:
In case a promotional piece on a prescription drug highlights the benefits of the product, the piece must also highlight at least one counter-indication and one frequent drug interaction.
For vaccines, the advertisement must inform of the necessary number of doses for the complete immunisation.
Products containing substances under special control, as defined in Ordinance 344/98 mentioned above, are subject to further regulation.
Advertising to prescribing professionals may contain information related to data held on file or to clinical studies that have not been included in the registration package, or even phase 4 studies. The information, however, must conform to the information (indication, dosage, etc) that have been approved by ANVISA and must be available to consultation if requested by healthcare professionals or by the authorities. Information that does not conform to the registration package, will be deemed as promotion of unauthorised use.
Pharmaceutical products in Brazil may only be promoted for the indications that are approved by ANVISA and such indications are included in the registration package. That said, for it to be possible to promote any product, even if in combination to another product, it would be necessary to amend the product registration to include this “combined use indication” in the product registration package and have it approved by ANVISA.
These are generally considered as scientific information and, as such, reprints may be distributed to healthcare professionals. There are no specific restrictions but the reprint should not come in a format that may resemble a promotional piece. For the distribution of reprints, the companies must have the authorisation of the author or of the media, as the case may be
There are no specific regulations related to Medical Science Liaisons (MSLs) who, in Brazil, are under the same rules applicable to pharmaceutical reps. Although most MSLs are, themselves, healthcare professionals, they cannot discuss unauthorised medicines or off-label indications.
No prior authorisation applies to advertising of medicines. However, RDC 096/2008 sets forth that the organisers of scientific events at which the advertising and promotion of medicinal products will take place, must inform ANVISA three months in advance of any such event, indicating the date and place of the event and the professional categories that will be invited to the event.
There are no arrangements or specific procedures (SOPs) required by law or regulation in relation to advertising or promotional activities.
Companies are free to establish them according to their own policies. Companies are also free to not even implement any SOPs to guide their promotional activities.
The internet is just another media and, as such, the same legislation and regulations that apply to the advertising of medicinal products in Brazil in traditional media, also apply to advertising on the internet so, only advertising of over-the-counter medicines is allowed.
If companies have internet sites that carry the include any type of promotion or advertisement of medicinal products, they need to ensure that advertising and promotion of prescription products can only be accessed by prescribing professionals.
RDC 096/2008 has only a few regulations that are specific to internet advertising. These regulate, for example, how warnings must appear (even indicating the type of font or requiring the use of bold fonts and capital letters in some specific cases).
It should be stressed that ANVISA does monitor health-related sites (pharmaceutical companies, pharmacies, distributors, clinics, etc) to make sure these rules are followed. However, exercising control on the content of internet sites is difficult as they exist in vast numbers and most of them contain a lot of information and countless different pages and/or links. That said, it is not common to see violation notices or fines applied for non-compliance with internet rules.
See 7.1 Regulation of Advertising Medicinal Products on the Internet.
As the promotion/advertising of prescription of medicines can only be made to healthcare professionals, any website containing advertising of these products must have access controls and restrictions.
Online disease awareness campaigns are allowed and, in fact, very common in Brazil. Brazilian health authorities are among the more common users of these campaigns and implement several of them each year especially related to vaccines, AIDS, hepatitis, flu, and tropical diseases. These campaigns that can be found in the internet sites of the Ministry of Health, States’ Health Departments and even Municipal Health Departments.
In any online disease awareness campaign, however, no specific medicinal product or trademark should be mentioned. The campaigns should simply provide an incentive for the population to consult with healthcare professionals for diagnosis or to go to doctors or health clinics (private or public) for diagnosis or vaccination.
The rules applicable to scientific meetings or congresses also apply to online events. Although there are no specific rules issued to online scientific meetings in Brazil, the sponsor should implement the same filters and controls required to presential events of the same nature. That said, these online meetings may or may not be considered international depending on the scope and on their content. No previous authorisation is needed.
In the same manner applicable to online advertisement of prescription-only drugs, the access to online materials must be subject to appropriate controls and restrictions during and after the online meeting or congress.
There are no anti-bribery/anti-corruption legislation or regulations specifically applicable to the interaction between pharmaceutical companies and healthcare professionals/organisations, or to the pharmaceutical industry in general.
Bribery and Corruption, in Brazil, are regulated by:
Anti-bribery/anti-corruption authorities will only investigate breaches related to advertising of pharmaceutical products to the extent that the breach constitutes an action of corruption or bribery.
As per applicable regulations, especially Resolution RDC 96/2008, pharmaceutical companies are not allowed to grant, offer, promise, or distribute gifts, benefits, and advantages:
The rules apply to both, individuals and/or organisations.
INTERFARMA also expressly regulates the issue in basically the same way as RDC 96/2008. Violation of the INTERFARMA code will subject the company to administrative penalties, like, for example, suspension or exclusion from the association and a pecuniary penalty that may be extremely steep.
It should be noted that the Federal Medicine Council, that regulates the medical profession, in its Code of Conduct, and Resolution 1.939/2010 prohibits physicians from participating in any advertisements or promotion of medical information for any promotional purposes and, also, to register patients or enrol them to participate in promotional actions like discount programs.
Companies may offer gifts to healthcare professionals, however, as per the applicable regulations only gifts of nominal value can be offered and these gifts must be of an “institutional” nature meaning that, they cannot bear marks or signs that can link them to any specific product. Some class associations like INTERFARMA, also require that the gifts:
Samples may be provided to healthcare professionals. A few exceptions apply and they are:
The procedures related to the distribution of samples are clearly regulated in RDC 096/2008 and in RDC 060/2009. Products containing substances under special control, eg, narcoleptics, that are included in Ordinance 344/1998 (controlled substances) are subject to additional regulations.
A free sample package must contain 50% of the quantity of original package. However, in the case of products for chronic diseases and a few other like contraceptives, samples must have the same quantity of the registered original. Samples of antibiotics must contain a complete treatment for one patient. Applicable regulations require that free sample packages are clearly and indelibly marked with the expression “free sample”.
The distribution of Free samples is limited to ambulatories, hospitals, medical doctors’ offices, and dentists’ offices. The prescribing professional receiving the samples must sign a document indicating receipt of the samples.
Regulations on samples, especially RDC 060/2009, require that holders of the product registration must keep on file, for a minimum of two years after each lot’s expiration date, all documents related to the production, distribution, and pharmacovigilance data of the free samples, even if not distributed, and must send to ANVISA, annually, information on the production and distribution of free samples.
The sponsorship of scientific events by pharmaceutical companies is allowed and is also regulated under RDC 096/2008, although there is no direct or specific regulation with a direct mention to hospitality.
The INTERFARMA Code of Conduct is more detailed that the ANVISA regulation and, does indicate that locations of primarily touristic appeal are not permitted. No approval from the local affiliate is required.
There is no specific threshold applicable, but venues and activities must not be interpreted as excessive or inappropriate for a healthcare event. Under the INTERFARMA Code, events should take place in the country where the organiser is located, except if the choice of a foreign country is justifiable by reasons of security or logistics.
It should be noted that payment or any type of remuneration, direct or indirect, for the time invested in the participation cannot be paid to participants. Also, payments for travel, accommodation, food, etc, are limited to the participant and cannot be extended to family members or other invitees of the doctor.
Pharmaceutical companies are allowed to organise and sponsor cultural, sports and any other event, provided that under the corporate trade marks of the companies. These types of events cannot be organised using the names or trade marks of prescription only drugs.
There is no specific regulation with direct and clear wording on this. However, throughout the applicable legislation and ancillary regulations it is made very clear that promotional actions towards prescribing professionals should not be (or be understood to be) in exchange for prescriptions of any product. In this case, also, it is advisable that grants and donations are regulated by contracts indicating the reason for the grant or the donation.
In relation to healthcare institutions these donations must also be of an institutional nature. Besides, they must, clearly, not be linked to any requirement or for the effect of serving as an incentive for the recipient institute to promote, advertise or, standardise the use of any medicinal product of the donor.
Donations should be covered by contracts that should have a specific clause to make this as evident as possible. The contracts may, and should, define the specific purpose of the donation and include clauses that give the donor the right to audit the use of the donations.
Under a regulatory point of view, there is no difference between monetary or equipment donations. Some donations may be subject to taxation and specific rules will apply.
Usually, rebates or discounts are granted to distributors and retailers. The industry is allowed to grant discounts and rebates provided that within commercial market practices and in line with the rules set forth in RDC 096/2008.
Companies may hire healthcare professionals to render any reasonable and justifiable professional services such as consulting services and review of dossiers, etc. Payment of the services must be within market practices.
When hiring professional services from healthcare professionals, a contract should be executed clearly delimiting the services to be provided. If a healthcare provider is hired to give classes and/or presentations at the start of any such class or presentation the doctor must indicate that they are receiving payment for that service as disclosure of potential conflict of interest.
Healthcare professionals either linked to Governmental Institutions or Private Companies must observe transparency and conflicts of interest norms set forth in their respective Employment Agreements and in the applicable Law. Usually, governmental employees are prevented from rendering services to any private companies even if there is no apparent conflict of interest. Governmental employees may give speeches and/or presentations but cannot be paid for it. In some cases, prior authorisation or notification may apply mostly for healthcare professionals employed by private companies.
Furthermore, organisers of scientific events at which the advertising and promotion of medicinal products will take place, are also required to inform ANVISA three months in advance of any such event, indicating the date and place of the event and the professional categories that will be invited to the event.
Resolution RDC 096/2008 requires that the healthcare professionals disclose to events’ organisers and participants any sponsorship by companies and or eventual conflict of interest.
There is no obligation to disclose the amount or details of any sponsorship. Speakers at events, symposia, congresses, etc., if they are sponsored by any company, must disclose this fact, at the start of their presentation and in the records of the events, if they exist.
It is important to point out that INTERFARMA’s Code of Conduct recommends making public receptors of sponsorships and donations.
See 10.1 Requirement for Pharmaceutical Companies to Disclose Details of Transfers of Value. In cases where the donor is a foreign company not subject to the Brazilian Law, authorisations and notifications, if any, should be addressed by the grantee.
Enforcement of advertising rules, is mainly exercised by ANVISA. The ANVISA department that holds the authority for supervising and judging advertising/promotional violations is located under the General Management in charge of Sanitary Inspection and Supervision (GGFIS).
As regulated by RDC 096/2008, the authorities also have the power to request that, if it is the case, corrective statements are issued and published by the companies.
Any final administrative decision, as per Brazilian law, may be submitted to the Judiciary if the regulated entity/individual believes the administrative decision does not conform to the law. Enforcement may also be sought through class associations like INTERFARMA, ABIMIP, or SINDUSFARMA.
Finally, in the case of non-prescription medicines, enforcement may be sought through CONAR.
Proceedings may be initiated by the Regulatory Authority “ex-officio” or by a competitor. The basis is, most of the time, some indication or evidence that the advertising rules have been breached by the accused party. Proceedings can be started before ANVISA and/or before any of the mentioned class associations.
Penalties imposed by ANVISA will range from:
The penalties imposed will depend on ANVISA’s evaluation on the gravity of the violation.
There is no relationship between the regulatory authority and the courts. However, the courts will tend to confirm decisions of the regulatory authority or class associations as they understand these bodies have a better technical knowledge of the field.
Recently, there has been a wave of comparative OTC advertisement and, given the speed necessary to block irregular advertising, CONAR has taken the lead in ruling those cases. The most significant decisions were about veracity of the comparisons and irregular use of trade mark in the advertisement (one leading case is: “CONAR representation 240/19”).